Pertuzumab: Today's The Day
 

For approval! Keep watch! I did just hear that they have a little wiggle room until next week, however!

Come on, FDA, let it go!

Karen

Re: Pertuzumab: Today's The Day
 

The novel monoclonal antibody pertuzumab, functions by preventing dimerization of HER-2 (the target of Herceptin) with other members of the human epidermal growth factor family: HER-1, HER-3 and HER-4. In doing so, the cross-talk between receptors is abrogated and downstream signaling is squelched. The most interesting aspect of this reflects the downstream pathways it targets. Pertuzumab inhibits signaling at the PI3K pathway, upstream from mTOR. In cell function analysis, this is the truest sense of the word, a breakthough in metabolomics. Much like genomics aims to unravel the structure of the genome, metabolomics focuses on understanding the many small molecule metabolites that result from a cell's metabolic processes.

http://her2support.org/vbulletin/showthread.php?t=54087

The Cancer “Breakthroughs” that Cost Too Much and Do Too Little

Perjeta is not a cure, added to standard treatment with Herceptin. Perjeta gives the average breast cancer patient only about six months more of calm before the disease starts to stir again. Given the limited benefit, the price is startling. A full course of the drug combination will cost $188,000.

Americans spent more than $23 billion last year for cancer drugs, more than we paid for prescriptions to treat anything else. But many oncologists are starting to question what we are getting in return for that bill, whether the war on cancer has become too much of a race to produce the next blockbuster.

http://www.thedailybeast.com/newswee...oo-little.html

Re: Pertuzumab: Today's The Day
 

Fingers x here across the pond! We soooooo love good news and this would certainly be that.
Ellie

Re: Pertuzumab: Today's The Day
 

I know. I know. I have my fingers crossed too.
Pertuzumab is going to help alot of people.

Re: Pertuzumab: Today's The Day
 

Also, Pertuzumab must be given with Herceptin.

Karen

Re: Pertuzumab: Today's The Day
 

Yay!!!! Fingers Crossed!

Re: Pertuzumab: Today's The Day
 

Approved!

FDA Approves Perjeta (Pertuzumab) for People With HER2-Positive Metastatic Breast Cancer


http://www.marketwatch.com/story/fda...cer-2012-06-08

Re: Pertuzumab: Today's The Day
 

Woo hoo! Every weapon helps!!!

Re: Pertuzumab: Today's The Day
 

Yayyyyyyyyyyyyyyyyy! Thank you, Jesus!!!!!!!!!!!!!!!!!!!!!!!!!!!!

Re: Pertuzumab: Today's The Day
 

Reading this is confusing me.

"Perjeta is approved in combination with Herceptin(R) (trastuzumab) and docetaxel chemotherapy for the treatment of people with HER2-positive metastatic breast cancer (mBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease."

Is this approved ONLY for patients who have not previously been treated with Herceptin and/or chemo?

Re: Pertuzumab: Today's The Day
 

"who have not received prior anti-HER2 therapy or chemotherapy"

Yeah..sure hope this is not enforced.

Re: Pertuzumab: Today's The Day
 

Ditto Vicki.

Re: Pertuzumab: Today's The Day
 

It reads to me first it is only for metastic her2 bc; second it is approved as first line treatment for metastic her2 bc. So if you haven't received any therapy for her2 metastic bc you are eligible for this drug combined with Herceptin and docetaxol
So for people whose disease has not progressed to stage 4, this will be the 1st line treatment once the disease progresses to stage 4.

Re: Pertuzumab: Today's The Day
 

"Who hasnt had herceptin if you are her2 positive? "

Good point. Methinks wires are crossed.

Re: Pertuzumab: Today's The Day
 

Me too, in that case nobody would get it. All will become clear soon and I suspect more trials will open to assess its use in other combinations
Ellie

Re: Pertuzumab: Today's The Day
 

Is the FDA only going to approve it for new her2 patients that are initially diagnosed at stage 4 and current her2 patients that become stage 4 but haven't been treated by Herceptin before? These articles are so hard for me to digest.

Re: Pertuzumab: Today's The Day
 

Although I am so happy to see the FDA approval, I have to admit I am sad and disappointed to read that it won't be available for stage 4 people like myself who are already on Herceptin. This just doesn't make any sense to me and makes me sad.

Re: Pertuzumab: Today's The Day
 

As I understand it, your doctor WILL be able to use it at his/her discretion. The "approval" was granted based on the study group.

Karen

Re: Pertuzumab: Today's The Day
 

The approval is for first line metastatic disease. So if you had adjuvant herceptin for early stage disease then later recurred as stage IV, this approval would apply to the first treatment AT STAGE IV.

The issue will be for those who have already had one or more treatments for metastatic disease.

As far as "enforcement", a doctor can generally prescribe an approved drug "off label", meaning for a different indication than the FDA approval. Example, for a patient who has already had one or more treatments in the metastatic setting.

The problem for access will be getting insurance to cover such off label use. That will be the big battle.

Re: Pertuzumab: Today's The Day
 

This approval is a start. Chrisy is right, it will be "off label" for non first-line patients and insurance coverage will depend on the carrier. There is a program in place, through Genentech, called Access Solutions that can contact insurance companies on behalf of the doctor and patient. There are other trials (like mine) for patients who have progressed on first-line treatment, and those studies are current and enrolling, so that is also an option.

Karen